This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.
Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
270
University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine
Greifswald, Germany
RECRUITINGpercentage of neonates requiring mechanical ventilation
duration of dependency on mechanical ventilation
major bleeding
heparin induced thrombocytopenia
anti PF4/heparin antibodies
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